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It is generally accepted that treatment with anti-amyloid antibodies can remove plaque from the brain, but whether such treatment can slow cognitive decline remains unclear. However, pharmaceutical company Eli Lilly, together with researchers from Indiana University and Brown University in the United States, recently reported that an anti-amyloid antibody, donanemab, may slow cognitive and functional decline in people with early Alzheimer’s disease.
The Phase 2 trial, published in the New England Journal of Medicine, randomly assigned 257 participants diagnosed with early symptomatic Alzheimer’s disease and who also displayed tau and amyloid deposits (hallmark features of Alzheimer’s disease) on a brain scan to receive donanemab or placebo intravenously every four weeks for up to 72 weeks. From baseline to 76 weeks follow-up, donanemab slowed decline compared to placebo, based on a composite measure for cognition and the ability to perform activities of daily living. The results for other outcomes, including clinical measures for dementia and biomarker endpoints, were mixed. Some participants who received donanemab experienced an adverse event, such as fluid build-up around the brain, infusion-related reactions and nausea.
Although the findings are encouraging, the researchers cautioned that longer and larger trials are necessary to study the efficacy and safety of donanemab in Alzheimer’s disease. As such, donanemab is not currently available to the public. The safety, tolerability and efficacy of donanemab continues to be evaluated in the international TRAILBLAZER-ALZ 2 trial. To learn more about TRAILBLAZER-ALZ 2, please visit the website https://trailblazer2study.com/.